FDA Reauthorization Act of 2017

Summary

FDA Reauthorization Act of 2017 Prescription Drug User Fee Amendments of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities. Medical Device User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill revises the types of medical devices that the FDA may accredit third parties to review. Generic Drug User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications. Biosimilar User Fee Amendments of 2017 The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees. The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships, support for development of medical products for rare conditions, and the program to conduct pediatric studies of drugs.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 16 May 2017

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

2. 16 May 2017

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 16 May 2017

   Introduced

   Introduced in House

   Source: IntroReferral

4. 16 May 2017

   Introduced

   Introduced in House

   Source: IntroReferral

5. 18 May 2017

   Committee

   Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

   Source: Committee

6. 18 May 2017

   Committee

   Subcommittee Consideration and Mark-up Session Held.

   Source: Committee

7. 7 June 2017

   Vote

   Ordered to be Reported (Amended) by the Yeas and Nays: 54 - 0.

   Source: Committee

8. 7 June 2017

   Committee

   Committee Consideration and Mark-up Session Held.

   Source: Committee

9. 11 July 2017

   Calendars

   Placed on the Union Calendar, Calendar No. 138.

   Source: Calendars

10. 11 July 2017

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-201.

    Source: Committee

11. 11 July 2017

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-201.

    Source: Committee

12. 12 July 2017

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

13. 12 July 2017

    Passed

    On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H5454-5477)

    Source: Floor

14. 12 July 2017

    Passed

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H5454-5477)

    Source: Floor

15. 12 July 2017

    Floor

    DEBATE - The House proceeded with forty minutes of debate on H.R. 2430.

    Source: Floor

16. 12 July 2017

    Floor

    Considered under suspension of the rules. (consideration: CR H5454-5483)

    Source: Floor

17. 12 July 2017

    Floor

    Mr. Walden moved to suspend the rules and pass the bill, as amended.

    Source: Floor

18. 13 July 2017

    Calendars

    Received in the Senate. Read the first time. Placed on Senate Legislative Calendar under Read the First Time.

    Source: Calendars

19. 17 July 2017

    Calendars

    Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 174.

    Source: Calendars

20. 1 August 2017

    Floor

    Motion to proceed to consideration of measure made in Senate. (CR S4663)

    Source: Floor

21. 3 August 2017

    Floor

    Motion to proceed to measure considered in Senate.

    Source: Floor

22. 3 August 2017

    Vote

    Passed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 94 - 1. Record Vote Number: 187.

    Source: Floor

23. 7 August 2017

    Floor

    Presented to President.

    Source: Floor

24. 7 August 2017

    President

    Presented to President.

    Source: President

25. 18 August 2017

    Became law

    Became Public Law No: 115-52.

    Source: President

26. 18 August 2017

    Became law

    Signed by President.

    Source: BecameLaw

27. 18 August 2017

    President

    Signed by President.

    Source: President

Votes

Versions

• Enrolled Bill · undated · Official file
• Public Law · 18 August 2017 · Official file
• Placed on Calendar Senate · 17 July 2017 · Official file
• Engrossed in House · 12 July 2017 · Official file
• Reported in House · 11 July 2017 · Official file
• Introduced in House · 16 May 2017 · Official file

Documents

16 official files

• Enrolled Bill (text)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

• Enrolled Bill (PDF)

  Enrolled Bill · EN

  ViewDownloadOpen at official source

• Public Law (text)

  Public Law · EN · 18 August 2017

  ViewDownloadOpen at official source

• Public Law (PDF)

  Public Law · EN · 18 August 2017

  ViewDownloadOpen at official source

• Public Law

  summary · EN · 18 August 2017

  Open at official source

• Passed Senate without amendment

  summary · EN · 3 August 2017

  Open at official source

• Placed on Calendar Senate (text)

  Placed on Calendar Senate · EN · 17 July 2017

  ViewDownloadOpen at official source

• Placed on Calendar Senate (PDF)

  Placed on Calendar Senate · EN · 17 July 2017

  ViewDownloadOpen at official source

• Engrossed in House (text)

  Engrossed in House · EN · 12 July 2017

  ViewDownloadOpen at official source

• Engrossed in House (PDF)

  Engrossed in House · EN · 12 July 2017

  ViewDownloadOpen at official source

• Passed House amended

  summary · EN · 12 July 2017

  Open at official source

• Reported in House (text)

  Reported in House · EN · 11 July 2017

  ViewDownloadOpen at official source

• Reported in House (PDF)

  Reported in House · EN · 11 July 2017

  ViewDownloadOpen at official source

• Introduced in House (text)

  Introduced in House · EN · 16 May 2017

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 16 May 2017

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 16 May 2017

  Open at official source

Sponsors

• GREG WALDEN · R · Sponsor
• Rep. Pallone, Frank [D-NJ-6] · D · Sponsor
• Michael Burgess · R · Sponsor
• GENE GREEN · D · Sponsor
• · hsif00 · Standing

Related records

• related to → Drug Diversion and Counterfeit Crackdown Act of 2017
• related to → FDA Reporting Transparency and Accountability Act
• related to → Pediatric Device Development Act
• related to → Over-the-Counter Hearing Aid Act of 2017
• related to → Over-the-Counter Hearing Aid Act of 2017
• related to → Enhanced Clinical Trial Design Act of 2017
• related to → Medical Device Safety Monitoring Act
• related to → FDA Reauthorization Act of 2017